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US09062X1037

"GAAP net income attributable to Biogen Inc."

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Inc. (NASDAQ: BIIB) today reported full year and fourth quarter
2015 results, including full year revenues of $10.8 billion, an 11%
increase versus 2014. Full year 2015 Non-GAAP diluted earnings per share
(EPS) were $17.01, an increase of 23% versus 2014. Non-GAAP net income
attributable to Biogen Inc. for the year was $3.9 billion, an increase
of 20% versus the prior year.

On a reported basis, GAAP diluted EPS for 2015 were $15.34, an increase
of 24% versus 2014. GAAP net income attributable to Biogen Inc. for 2015
was $3.5 billion, an increase of 21% versus 2014. (A reconciliation of
GAAP to Non-GAAP full year and quarterly financial results can be found
in Table 3 at the end of this release).

“We saw solid performance in our industry leading multiple sclerosis
portfolio and strong adoption of our hemophilia therapies,” said Chief
Executive Officer George A. Scangos, Ph.D. “We continue to make
investments in important and promising programs that we believe have the
potential to help people suffering from devastating diseases, and we are
also excited about the potential to launch three new products this year:
BENEPALI®, ZINBRYTATM, and an infliximab
biosimilar.”

“The year ahead will be very exciting for our pipeline, as we look to
advance several potential breakthrough programs,” Dr. Scangos continued.“We are executing two Phase 3 clinical trials for aducanumab in
Alzheimer’s disease, and are awaiting new data from two other
Alzheimer’s candidates. We are encouraged by open label Phase 2 data for
nusinersen for spinal muscular atrophy, the leading genetic cause of
infant mortality, and are advancing two Phase 3 studies in infants and
children with our collaboration partner Ionis. We expect to see Phase 2
data for anti-LINGO in multiple sclerosis in the middle of the year,
allowing us to better understand its potential to reverse or repair
damage caused by the disease. We are also focused on expanding our
leadership in neurology by continuing to attract top talent and using
new technology, novel science and a better understanding of disease
biology to pursue early stage programs in areas such as Parkinson’s
disease and ALS.”

Full Year 2015 Financial Highlights

TECFIDERA® revenues were $3.6 billion compared to $2.9
billion in 2014. These results consisted of $2.9 billion in U.S. sales
and $730 million in sales outside the U.S. compared to $2.4 billion
and $483 million, respectively, in 2014.

Interferon revenues, including AVONEX® and PLEGRIDY®,
were $3.0 billion compared to $3.1 billion in 2014. These results
consisted of $2.0 billion in U.S. sales and $951 million in sales
outside the U.S. compared to $2.0 billion and $1.1 billion,
respectively, in 2014.

TYSABRI® revenues were $1.9 billion compared to $2.0
billion in 2014. These results consisted of $1.1 billion in U.S. sales
and $783 million in sales outside the U.S. compared to $1.0 billion
and $934 million, respectively, in 2014.

Net revenues relating to RITUXAN® and GAZYVA®
from our unconsolidated joint business arrangement were $1.3 billion
compared to $1.2 billion in 2014.

ELOCTATE® revenues were $320 million compared to $58
million in 2014.

ALPROLIX® revenues were $234 million compared to $76
million in 2014.

Revenues for FAMPYRATM and FUMADERM™ were $141 million
compared to $143 million in 2014.

Royalty revenues were $48 million compared to $177 million in 2014.

Corporate partner revenues were $189 million compared to $128 million
in 2014.

Foreign exchange, offset by $166 million in net hedging gains,
weakened total revenues by approximately $227 million compared to 2014.

TECFIDERA revenues were $993 million compared to $916 million in the
same quarter last year. These results consisted of $785 million in
U.S. sales and $208 million in sales outside the U.S. compared to $743
million and $173 million, respectively, in the fourth quarter of 2014.
TECFIDERA U.S. sales included 13 shipping weeks in the fourth quarter
of 2015 versus 14 in the fourth quarter of 2014.

TECFIDERA revenues in the fourth quarter of 2015 increased 6%
versus the third quarter of 2015, including a 4% increase in U.S.
revenues, which benefited by approximately $30 million due to an
increase of inventory in the wholesale channel.

Interferon revenues, including AVONEX and PLEGRIDY, were $740 million
compared to $777 million in the same quarter last year. These results
consisted of $506 million in U.S. sales and $233 million in sales
outside the U.S. compared to $528 million and $249 million,
respectively, in the fourth quarter of 2014. AVONEX U.S. sales
included 13 shipping weeks in the fourth quarter of 2015 versus 14 in
the fourth quarter of 2014.

TYSABRI revenues were $481 million compared to $484 million in the
same quarter last year. These results consisted of $278 million in
U.S. sales and $203 million in sales outside the U.S. compared to $266
million and $218 million, respectively, in the fourth quarter of 2014.

Net revenues relating to RITUXAN and GAZYVA from our unconsolidated
joint business arrangement were $334 million compared to $305 million
in the same quarter last year.

ELOCTATE revenues were $101 million compared to $37 million in the
same quarter last year.

ALPROLIX revenues were $71 million compared to $40 million in the same
quarter last year.

Revenues for FAMPYRA and FUMADERM were $40 million compared to $33
million in the same quarter last year.

Royalty revenues were $10 million compared to $31 million in the same
quarter last year.

Corporate partner revenues were $69 million compared to $18 million in
the same quarter last year.

Corporate partner revenues in the fourth quarter of 2015 increased
74% versus the third quarter of 2015 related to contract
manufacturing for Samsung Bioepis and another strategic partner.

Foreign exchange, offset by $40 million in net hedging gains, weakened
total revenues by approximately $35 million compared to the same
quarter last year.

Non-GAAP SG&A expense was $583 million compared to $573 million in the
same quarter last year. GAAP SG&A expense was $583 million compared to
$574 million in the same quarter last year.

Non-GAAP R&D expense was $542 million compared to $499 million in the
same quarter last year. GAAP R&D expense was $542 million compared to
$500 million in the same quarter last year.

GAAP diluted EPS were $3.77, an increase of 1% versus the fourth
quarter of 2014. GAAP net income attributable to Biogen for the
quarter was $832 million, a decrease of 6% versus the fourth quarter
of 2014. GAAP results in 2015 include the impact of a $93 million
pretax restructuring charge for employee severance and R&D program
termination costs in connection with the cost reduction initiative
announced in October 2015.

Non-GAAP diluted EPS were $4.50, an increase of 10% versus the fourth
quarter of 2014. Non-GAAP net income attributable to Biogen for the
quarter was $995 million, an increase of 3% from the fourth quarter of
2014.

Capital Allocation Highlights

In 2015, Biogen purchased approximately 16.8 million shares of its
common stock, completing its previously authorized $5.0 billion share
repurchase program.

For 2015, the Company’s full year weighted average diluted shares were
231 million. For the fourth quarter of 2015, the Company’s weighted
average diluted shares were 221 million. The Company ended the year
with approximately 219 million basic shares outstanding.

At the end of 2015, Biogen had cash, cash equivalents and marketable
securities totaling approximately $6.2 billion, and $6.5 billion in
notes payable and other financing arrangements.

2016 Financial Guidance

Biogen also announced its full year 2016 financial guidance. This
guidance consists of the following components:

Revenue is expected to be approximately $11.1 to $11.3 billion.

R&D expense is expected to be approximately 19% to 20% of total
revenue.

The Company plans to continue to invest in a number of R&D
programs across its emerging mid- and late-stage pipeline,
including aducanumab for Alzheimer’s disease, nusinersen for
spinal muscular atrophy, raxatrigine for trigeminal neuralgia and
amiselimod for inflammatory bowel disease.

SG&A expense is expected to be approximately 17% to 18% of total
revenue.

The Company anticipates an approximately 200 basis point
improvement over 2015 driven by the headcount reduction announced
in October 2015 as well as a reduction in fees and services
expenses.

Non-GAAP diluted EPS is expected to be between $18.30 and $18.60.

GAAP diluted EPS is expected to be between $16.85 and $17.15.

Biogen may incur charges, realize gains or experience other events in
2016 that could cause actual results to vary from this guidance.

In 2016, the Company plans to provide one update to its annual financial
guidance, which is expected to be provided in connection with its second
quarter earnings release. This approach is intended to synchronize
guidance with internal business planning processes and to ensure a
continued focus on long-term value creation.

Recent Company Events

In November 2015, Biogen and Swedish Orphan Biovitrum AB (Sobi)
announced that the European Commission approved ELOCTA®
(rFVIIIFc) for the treatment of hemophilia A in all 28 European Union
(EU) member states, as well as Iceland, Liechtenstein and Norway.
ELOCTA, the trade name for ELOCTATE in Sobi’s territory, is the first
hemophilia A treatment in the EU to offer prolonged protection against
bleeding episodes with prophylactic injections every three to five
days. Sobi will lead commercialization in Europe.

In December 2015, Biogen presented new data demonstrating that
ELOCTATE and ALPROLIX may effectively manage target joint bleeding and
maintain low annualized bleeding rates in people with severe
hemophilia A and B. The data were presented by Biogen and Sobi at the
57th American Society of Hematology (ASH) Annual Meeting
and Exposition.

In December 2015, Biogen initiated a Phase 1/2 clinical study of
IONIS-SOD1Rx (BIIB067) in patients with amyotrophic lateral
sclerosis (ALS), including patients with a mutation in superoxide
dismutase 1 (SOD1), which accounts for approximately 2% of ALS
patients. IONIS-SOD1Rx is an antisense oligonucleotide
designed to reduce the production of SOD1 and is being developed in
collaboration with Ionis Pharmaceuticals.

In January 2016, Samsung Bioepis, the joint venture between Biogen and
Samsung Biologics, received approval from the European Commission for
BENEPALI, the first etanercept biosimilar referencing Enbrel®
to be approved in the EU. BENEPALI will be manufactured and
commercialized in the EU by Biogen and is the first product from its
biosimilar pipeline to be approved.

Conference Call and WebcastThe Company's earnings
conference call for the fourth quarter will be broadcast via the
internet at 8:30 a.m. EST on January 27, 2016, and will be accessible
through the Investors section of Biogen’s homepage, www.biogen.com.
Supplemental information in the form of a slide presentation will also
be accessible at the same location on the internet at the time of the
conference call and will be subsequently available on the website for at
least one month.

About BiogenThrough cutting-edge science and medicine,
Biogen discovers, develops and delivers to patients worldwide innovative
therapies for the treatment of neurodegenerative diseases, hematologic
conditions and autoimmune disorders. Founded in 1978, Biogen is one of
the world’s oldest independent biotechnology companies and patients
worldwide benefit from its leading multiple sclerosis and innovative
hemophilia therapies. For product labeling, press releases and
additional information about the Company, please visit www.biogen.com.

Safe HarborThis press release contains forward-looking
statements, including statements relating to: Biogen’s commercial
business and prospects; investments in, and potential of, pipeline and
collaboration programs; anticipated timing of data readouts; potential
product approvals and timing of launches; 2016 full year guidance and
other financial matters. These forward-looking statements may be
accompanied by such words as “anticipate,” “believe,” “could,”
“estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,”
“project,” “target,” “will” and other words and terms of similar
meaning. You should not place undue reliance on these statements.

These statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such statements,
including: our dependence on sales from our principal products; failure
to compete effectively due to significant product competition in the
markets for our products; difficulties in obtaining and maintaining
adequate coverage, pricing and reimbursement for our products; risks
associated with current and potential future healthcare reforms; the
occurrence of adverse safety events, restrictions on use with our
products or product liability claims; failure to protect and enforce our
data, intellectual property and other proprietary rights and the risks
and uncertainties relating to intellectual property claims and
challenges; uncertainty of long-term success in developing, licensing or
acquiring other product candidates or additional indications for
existing products; risks associated with clinical trials, including our
ability to adequately manage clinical activities, unexpected concerns
that may arise from additional data or analysis obtained during clinical
trials, regulatory authorities may require additional information or
further studies or may fail to approve or may delay approval of our drug
candidates; the risk that positive results in a clinical trial may not
be replicated in subsequent or confirmatory trials or success in early
stage clinical trials may not be predictive of results in later stage or
large scale clinical trials or trials in other potential indications;
problems with our manufacturing processes; our dependence on
collaborators and other third parties for the development and
commercialization of products and other aspects of our business, which
are outside of our control; failure to manage our growth and execute our
growth initiatives; failure to achieve the anticipated benefits and
savings from our corporate restructuring efforts; risks relating to
technology failures or breaches; failure to comply with legal and
regulatory requirements; risks related to indebtedness; the risks of
doing business internationally, including currency exchange rate
fluctuations; charges and other costs relating to our properties;
fluctuations in our effective tax rate; risks relating to investment in
and expansion of manufacturing capacity for future clinical and
commercial requirements; the market, interest and credit risks
associated with our portfolio of marketable securities; risks relating
to our ability to repurchase stock, including at favorable prices; risks
relating to access to capital and credit markets; environmental risks;
risks relating to the sale and distribution by third parties of
counterfeit versions of our products; risks relating to the use of
social media for our business; change in control provisions in certain
of our collaboration agreements; and the other risks and uncertainties
that are described in the Risk Factors section of our most recent annual
or quarterly report and in other reports we have filed with the SEC.

These statements are based on our current beliefs and expectations and
speak only as of the date of this press release. We do not undertake any
obligation to publicly update any forward-looking statements.

An itemized reconciliation between net income attributable to Biogen
Inc. on a GAAP basis and on a Non-GAAP basis is as follows:

For the Three Months

For the Twelve Months

Ended December 31,

Ended December 31,

2015

2014

2015

2014

GAAP net income attributable to Biogen Inc.

$

831.6

$

883.5

$

3,547.0

$

2,934.8

Adjustments:

Amortization of acquired intangible assets

92.0

101.4

365.3

472.9

(Gain) loss on fair value remeasurement of contingent consideration

24.6

7.3

30.5

(38.9

)

Restructuring charges

93.4

-

93.4

-

SG&A: Stock option expense

-

1.1

-

6.4

R&D: Stock option expense

-

1.0

-

5.8

Donation to Biogen Foundation

-

-

-

35.0

Income tax effect related to reconciling items

(46.9

)

(28.7

)

(104.3

)

(134.9

)

Non-GAAP net income attributable to Biogen Inc.

$

994.7

$

965.6

$

3,931.9

$

3,281.1

2016 Full Year Guidance: GAAP to Non-GAAP Reconciliation

An itemized reconciliation between projected net income attributable
to Biogen Inc. and diluted earnings per share on a GAAP basis and on
a Non-GAAP basis is as follows:

$

Shares

Diluted EPS

Projected GAAP net income attributable to Biogen Inc.

$

3,722.0

218.8

$

17.01

Adjustments:

Amortization of acquired intangible assets

350.0

(Gain) loss on fair value remeasurement of contingent consideration

20.0

Restructuring charges

10.0

Income tax effect related to reconciling items

(65.0

)

Projected Non-GAAP net income attributable to Biogen Inc.

$

4,037.0

218.8

$

18.45

Numbers may not foot due to rounding.

Use of Non-GAAP Financial Measures

We supplement our consolidated financial statements presented on a GAAP
basis by providing additional measures which may be considered
“non-GAAP” financial measures under applicable SEC rules. We believe
that the disclosure of these non-GAAP financial measures provides
additional insight into the ongoing economics of our business and
reflects how we manage our business internally, set operational goals
and forms the basis of our management incentive programs. These non-GAAP
financial measures are not in accordance with generally accepted
accounting principles in the United States and should not be viewed in
isolation or as a substitute for reported, or GAAP, net income
attributable to Biogen Inc. and diluted earnings per share.

Our “Non-GAAP net income attributable to Biogen Inc.” and “Non-GAAP
earnings per share - Diluted” financial measures exclude the following
items from "GAAP net income attributable to Biogen Inc." and "GAAP
earnings per share - Diluted":

1. Purchase accounting and merger-related
adjustments.

We exclude certain purchase accounting related items associated with the
acquisition of businesses, assets and amounts in relation to the
consolidation of variable interest entities for which we are the primary
beneficiary. These adjustments include charges for in-process research
and development, the amortization of certain acquired intangible assets
and fair value remeasurement of our contingent consideration obligations.

2. Stock option expense recorded in accordance
with the accounting standard for share-based payments.

3. Other items.

We evaluate other items on an individual basis, and consider both the
quantitative and qualitative aspects of the item, including (i) its size
and nature, (ii) whether or not it relates to our ongoing business
operations, and (iii) whether or not we expect it to occur as part of
our normal business on a regular basis. We also include an adjustment to
reflect the related tax effect of all reconciling items within our
reconciliation of our GAAP to Non-GAAP net income attributable to Biogen
Inc.